Associate Director, Regulatory Operations

Regulatory Jobs; Princeton (NJ); Ibrido; USD 146.000 - 183.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental, vision insurance

401(k) plan with company match

Employee Stock Purchase Plan

Vacation and paid holidays

Descrizione del lavoro

Acadia Pharmaceuticals is seeking an Associate Director of Regulatory Operations to lead global regulatory submissions, RIM, and document management. This role drives submission planning, maintains inspection-ready records, and partners with cross-functional teams and external providers to ensure compliant, efficient processes.

A strong background in eCTD, EDMS, and global regulations is required. The position supports hybrid work arrangements across US sites, including Princeton, NJ, with

Competenze

• Bachelor's degree in a scientific discipline or related field; equivalent combination considered.
• 8+ years in regulatory operations in pharma/biotech.
• Strong expertise in the eCTD process and publishing software.
• Experience overseeing electronic document management systems (EDMS).
• Thorough knowledge of US/international regulations for Regulatory Operations.

Mansioni

• Lead planning, preparation, formatting, publishing, and archiving of global regulatory submissions.
• Coordinate submission deliverables for INDs, CTAs, NDAs, MAAs, and related documents.
• Provide guidance translating regulatory strategy into operational plans and mitigate risks.
• Ensure compliance with health authority standards and internal procedures.
• Escalate and resolve submission, publishing, document, process, and technology issues.

Conoscenze

Bachelor's degree

Regulatory operations

eCTD process

EDMS oversight

Regulatory knowledge US/Intl

Cross-functional collaboration

Travel ability

Analytical skills

Communication skills

Formazione

Bachelor's degree or equivalent

Strumenti

EDMS systems

Publishing software

RIM tools

Descrizione del lavoro

About Acadia Pharmaceuticals

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference.

Please note that this position can be based in San Diego, CA, San Francisco, CA, or Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Associate Director, Regulatory Operations provides leadership for global regulatory submissions, regulatory information management, document management, and related technology. This role leads regulatory submission planning and delivery for assigned development and marketed products, serves as a subject matter expert for electronic document management, publishing, and Regulatory Information Management systems. The Associate Director partners with Regulatory Affairs and other cross-functional stakeholders, including external service providers to maintain compliant, efficient, inspection-ready processes and systems. The position operates with a high degree of independence, resolves complex operational and technical issues, and drives continuous improvement through governance, metrics, data quality, automation, and emerging technology.

Primary Responsibilities

Regulatory Submission Operations

• Lead and oversee the planning, preparation, formatting, assembly, publishing, quality control, dispatch, and archiving of global regulatory submissions and correspondence
• Coordinate submission deliverables for applications and lifecycle activities, including INDs, CTAs, NDAs, MAAs, amendments, supplements, health authority responses, and briefing documents
• Provide tactical guidance to global regulatory teams, translate regulatory strategy into executable operational plans, and identify and mitigate submission risks
• Interpret and apply current electronic submission standards, health authority technical requirements, internal policies, and operating procedures
• Serve as a point of escalation for submission, publishing, document, process, and technology issues; drive timely resolution with internal teams, IT and vendors
• Maintain complete, traceable, accurate, and readily retrievable regulatory records to support inspection readiness

Regulatory Information and Document Management

• Provide business ownership and operational leadership for assigned RIM and electronic document management capabilities, including registrations, submissions, submission archives, document metadata, records lifecycle management, dictionaries, and user administration
• Lead and support system governance and administrative processes, including access management, user training and experience, issue management, configuration, change control, release management, validation documentation, and ongoing operational support
• Partner with stakeholders to gather and translate business requirements into scalable system and process solutions
• Ensure regulatory information, documents, and records are managed in accordance with applicable regulations, company procedures, and validated-system requirements

Technology, Validation, and Continuous Improvement

• Partner with Information Technology, Quality, other business owners, and vendors on system implementations, upgrades, integrations, validation, and operational support
• Support validation activities, including user needs, requirements, risk assessment, test planning, test script authoring and execution, defect resolution, and release readiness
• Evaluate evolving regulations, industry practices, system capabilities, artificial intelligence, automation, and emerging technologies; recommend and implement fit-for-purpose improvements and participate in industry forums and represent Acadia at relevant conferences/events
• Lead process optimization and system configuration initiatives that improve quality, compliance, efficiency, usability, and transparency
• Develop and maintain SOPs, work instructions, standards, templates, checklists, governance documents, and training materials

Business Partnership

• Act as a trusted Regulatory Operations advisor to global regulatory teams and cross-functional partners
• Lead cross-functional initiatives and taskforces; influence decisions and promote consistent global practices without relying on formal authority
• Oversee external vendors, consultants, and contractors, including scope, quality, timelines, performance, and budget responsibilities
• May oversee and develop junior personnel and project team members, as assigned
• Other responsibilities as assigned

Education/Experience/Skills

• Bachelor’s degree in scientific discipline or related field. An equivalent combination of relevant education and experience may be considered
• Targeting 8 years of regulatory operations experience within the pharmaceutical or biotech industry
• Must have strong expertise in the eCTD process, oversight of electronic document management systems, and publishing software and tools
• Must have technical expertise in EDMS oversight
• Thorough knowledge of US and international regulations as they apply to Regulatory Affairs Operations
• Ability to influence and partner cross-functionally
• Self-organized, self-directing, and highly motivated
• Strong critical thinking and analytical skills
• Demonstrated ability to contribute to a continuous learning and process improvement environment
• Excellent verbal and written organizational and communication skills
• Willingness and ability to travel domestically and internationally as needed

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-RE1 #LI-HYBRID

In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.

Salary Range

$146,000—$182,500 USD

What we offer US-based Employees:

• Competitive base, bonus, new hire and ongoing equity packages
• Medical, dental, and vision insurance
• Employer-paid life, disability, business travel and EAP coverage
• 401(k) Plan with a fully vested company match 1:1 up to 5%
• Employee Stock Purchase Plan with a 2-year purchase price lock-in
• 15+ vacation days
• 13 -15 paid holidays, including office closure between December 24th and January 1st
• 10 days of paid sick time
• Paid parental leave benefit
• Tuition assistance

EEO Statement (US-based Employees):

Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.

It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.

As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquiry about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at [e-mail] or 858-261-2923.

Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodations given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.

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